Abstract 1384P
Background
Treatment intensification with novel hormonal therapies (NHT) or docetaxel (DOC) in mCSPC is standard of care. However, recent studies show underutilization of treatment intensification, even for patients with more aggressive disease characteristics (eg, visceral metastases). Whether introduction of NHT and DOC over time has improved real-world OS in patients with mCSPC is unknown.
Methods
Medicare (MC) and Veterans Health Administration (VA) data were retrospectively studied for patient characteristics, treatment patterns, and OS in men with mCSPC treated with androgen deprivation therapy (ADT) ± first generation non-steroidal antiandrogens (NSAA), DOC, or NHT from 2010 to 2018 (MC) / 2019 (VA). Kaplan-Meier and Cox models adjusting for baseline characteristics were used to estimate OS in 3 cohorts: those treated before (2010–2011) and after (2012–2014) guideline recommendations for NHT use in metastatic castration-resistant prostate cancer (mCRPC) and after recommendations for DOC or NHT in mCSPC (2015–2018/2019).
Results
We identified 33,641 MC and 5,651 VA men with mCSPC with a mean age of 76.6 and 73.0, respectively. Patient characteristics were mostly similar over time, albeit with increasing prevalence of nodal metastases. Over time, the use of ADT alone and ADT + NSAA declined, and the use of ADT + DOC and ADT + NHT increased, though they remained low. Nonetheless, as of 2018/2019, less than one third of patients with mCSPC received first-line ADT + DOC or ADT + NHT. After adjusting for baseline characteristics, OS did not improve in 2012–2014 compared with 2010–2011 but did improve by 12% and 15% in MC and the VA, respectively, in 2015–2018/2019 vs 2010–2011 (Table). Table: 1384P
Treatment allocations and OS by treatment initiation year
| 2010–2011 MC / VA | 2012–2014 MC / VA | 2015–2018/2019 MC / VA | |
| N | 4,967 / 679 | 9,471 / 1,377 | 19,203 / 3,595 |
| Age at index date, mean ± standard deviation | 76.6 ± 8.2 / 73.7 ± 10.3 | 76.6 ± 8.0 / 72.4 ± 10.1 | 76.5 ± 7.8 / 73.1 ± 9.5 |
| Any visceral metastases, n (%) | 515 (10.4) / 72 (10.6) | 982 (10.4) / 136 (9.9) | 2,036 (10.6) / 362 (10.1) |
| ADT ± NSAA, n (%) | 4,929 (99.2) / 671 (98.9) | 9,281 (98.0) / 1,334 (96.9) | 17,247 (89.8) / 2,889 (80.3) |
| ADT + DOC, n (%) | 37 (0.7) / 6 (0.9) | 127 (1.3) / 21 (1.5) | 1,015 (5.3) / 204 (5.7) |
| ADT + NHT, n (%) | <11 (<1.0) / 2 (0.3) | 63 (0.7) / 22 (1.6) | 941 (4.9) / 502 (14.0) |
| OS: Adjusted hazard ratio (p-value) vs 2010–2011 | - | 0.97 (0.221) / 0.96 (0.482) | 0.88 (<0.001) / 0.85 (0.002) |
Conclusions
OS improvement in 2015–2018/2019 in men treated for mCSPC coincided with the introduction of DOC and NHT in mCSPC. However, the underutilization of these agents in mCSPC suggests that further OS improvements may be possible.
Clinical trial identification
Editorial acknowledgement
Medical writing and editorial support funded by the sponsors was provided by Matthieu Larochelle of Onyx, a Prime Global agency.
Legal entity responsible for the study
Pfizer and Astellas Pharma.
Funding
Pfizer and Astellas Pharma.
Disclosure
D.J. George: Financial Interests, Personal, Other, Consultant: Advanced Accelerator Applications SA/Novartis, Aveo Pharmaceuticals, Eisai, IdeoOncology, Merck Sharp & Dohme, Myovant Sciences, Inc., Propella Therapeutics, RevHealth, LLC, Seattle Genetics, WebMD, Xcures; Financial Interests, Personal, Other, Sr. Editor: American Association for Cancer Research; Financial Interests, Personal, Advisory Board: Astellas; Financial Interests, Personal, Advisory Board, CAPI-281 Steering Committee member: AstraZeneca; Financial Interests, Personal, Invited Speaker, and Consultant: Bayer H/C Pharmaceuticals, Exelixis, Inc.; Financial Interests, Personal, Other, Consultant/IDMC member: Janssen Pharmaceuticals; Financial Interests, Personal, Other, Contributor: Medscape Education; Financial Interests, Personal, Other, Honorarium, Consultant: Michael J Hennessey Associates; Financial Interests, Personal, Other, Co-Editor-in-Chief: Millennium Medical Publishing, Clinical Advances in Hematology & Oncology; Financial Interests, Personal, Other, Steering Committee member: NCI Genitourinary (Leidos biomedical Research); Financial Interests, Personal, Other, Consultant, Steering Committee member, Honorarium: Pfizer; Financial Interests, Personal, Other, Consultant, Speaker, Honorarium: Sanofi; Financial Interests, Personal, Other, Honorarium: UroGPO; Financial Interests, Personal, Other, Honorarium, Travel Accommodations: UroToday; Financial Interests, Personal, Expert Testimony: WilmerHale Attorneys; Financial Interests, Institutional, Funding: Astellas, AstraZeneca, Bristol Myers Squibb, Calithera, Exelisix, Janssen Pharmaceuticals, Novartis, Pfizer, Sanofi. R. Sandin: Financial Interests, Personal, Full or part-time Employment: Pfizer; Financial Interests, Personal, Stocks/Shares: Pfizer. N. Agarwal: Financial Interests, Personal, Other, Consultancy: Astellas, AstraZeneca, Aveo, Bayer, Bristol Myers Squibb, Calithera, Clovis, Eisai, Eli Lilly, EMD Serono, Exelixis, Foundation Medicine, Genentech, Gilead, Janssen, Merck, MEI Pharma, Nektar, Novartis, Pfizer, Pharmacyclics, Seattle Genetics; Financial Interests, Institutional, Research Grant: Astellas, AstraZeneca, Bavarian Nordic, Bayer, Bristol Myers Squibb, Calithera, Celldex, Clovis, Eisai, Eli Lilly, EMD Serono, Exelixis, Genentech, Gilead, Glaxo Smith Kline, Immunomedics, Janssen, Medivation, Merck, Nektar, New Link Genetics, Novartis.
S.T. Tagawa: Financial Interests, Personal, Advisory Role: Astellas Pharma, Bayer, Tolmar, Genentech, Endoyte, Immunomedics, Karyopharm Therapeutics, Novartis, Genomic Health, QED, Medivation, Janssen, Amgen, Pfizer, POINT Biopharma, Dendreon, AbbVie, Sanofi, Clovis Oncology; Financial Interests, Institutional, Research Grant: Janssen, Millennium, Merck, Clovis Oncology, Bayer, Stem CentRx, Medivation, Rexahn Pharmaceuticals, Inovio Pharmaceuticals, Endocyte, Lilly, Astellas Pharma, Amgen, Novartis, Boehringer Ingelheim, Bristol Myers Squibb, AstraZeneca, AVEO, Exelixis, Progenics, Newlink Genetics, Immunomedics, Sanofi, Karyopharm Therapeutics, Dendreon, Genentech, AbbVie; Financial Interests, Personal, Other, Travel, accommodation, and expenses: Amgen, Sanofi, Immunomedics; Non-Financial Interests, Personal, Other: Telix Pharmaceuticals, Phosplatin Therapeutics, ATLAB Pharma. Z. Klaassen: Financial Interests, Personal, Advisory Board: Myovant/Pfizer; Financial Interests, Personal, Speaker’s Bureau: Lantheus. K. Ramaswamy: Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Personal, Stocks/Shares: Pfizer; Financial Interests, Personal, Other, Travel, accommodation, and expenses: Pfizer. B. Emir, C. Bland: Financial Interests, Personal, Full or part-time Employment: Pfizer; Financial Interests, Personal, Stocks/Shares: Pfizer. A. Hong: Financial Interests, Personal, Full or part-time Employment: Astellas Pharma; Financial Interests, Personal, Stocks/Shares: AbbVie, Merck, Veru. L. Shi: Financial Interests, Personal, Ownership Interest: BRAVO4HEALTH LLC; Financial Interests, Institutional, Principal Investigator: NIH, CDC. H. Yang: Financial Interests, Personal, Full or part-time Employment: Analysis Group, Inc. W. Gao: Financial Interests, Personal, Full or part-time Employment: Analysis Group, Inc. W. Song: Financial Interests, Personal, Full or part-time Employment: Analysis Group, Inc. S. Freedland: Financial Interests, Personal, Advisory Role: Astellas Pharma, AstraZeneca, Bayer, Clovis Oncology, Dendreon, Ferring, Janssen, Myovant Sciences, Pfizer, Sanofi; Financial Interests, Institutional, Research Grant: Bayer, Diasorin, GenomeDx, Janssen, MDxHealth, Merck, Myriad Genetics, OPKO Diadnostics, Progenika; Financial Interests, Personal, Other, Travel, accommodation, and expenses: Sanofi. All other authors have declared no conflicts of interest.